Intego - Mycoplasma Testing
ATMP manufacturer, pharmaceutical industry, media manufacturer.
Direct mycoplasma testing method especially designed for cell culture materials and ATMPs according to EP 2.6.7.
Recommended Sample Material
Cell cultures, cryo-stocks, sera, antibody formulations, autologous material and many more.
Qualitative Real-Time PCR.
Applied PCR System
Microsart® ATMP Mycoplasma (Sartorius Biotech GmbH), Venor GeM qEP (Minerva Biolabs GmbH).
InviMag I/G Universal (Stratec Molecular GmbH), QiaAMP DSP Virus Spin Kit (Qiagen AG) and Venor GeM Sample Preparation Kit (Minerva Biolabs GmbH).
Extraction and Amplification.
Sample Volume / PCR
Average Turnaround Time
24 to 48 hours after sample receipt, express testing scheme* possible.
Sensitivity of Method
10 CFU / ml.
EP 2.6.7 compliant for ATMPs. Please note, a validated procedure is available for standard sample materials only. For any other materials an individual validation may be required to demonstrate the efficiency of the pre-analytical procedure in means of sensitivity. Please contact us for further information.
Mycoplasma Testing ‘Intego’ 41-1012
Volume Discount Available
Yes, on request.
Please note: repetitions which are not caused by our laboratory and *express testing schemes are subject to additonal charges. Please contact us for further information.